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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
2021

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test

Test material

Constituent 1
Reference substance name:
A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate; propylene carbonate
EC Number:
403-490-8
EC Name:
A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate; propylene carbonate
IUPAC Name:
403-490-8

Method

Target gene:
n/a
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced S9-mix
Test concentrations with justification for top dose:
Concentration range in the main test (with metabolic activation): 10 ... 200 µg/ml
Concnetration range in the main test (without metabolic activation): 10 ... 200 µg/ml
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Details on test system and experimental conditions:
Fixation time (start of exposure up to fixation or harvest of cells):
With metabolic activation: 7, 18 and 28 hr
Without metabolic activation: 7, 18 and 28 hr

Second experiment: without metabolic activation: 28 hr

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
True negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
Treatment with concentrations higher than 25.0 µg/ml reduced the plating efficiency of the V79 cells. Also the mitotic index was reduced after treatment with the highest scorable concentration at all fixation intervals in the absence of S9-mix. In the presence of S9-mix a reduction was observed at interval 18 hr.

Applicant's summary and conclusion

Conclusions:
Negative with and without metabolic activation